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CTRI Number  CTRI/2025/08/092995 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Occupational Therapy ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Improving Flexibility in Daily Routines: The Impact of Combined Sensory Integration and Behavioral Interventions for Children with Autism Spectrum Disorder 
Scientific Title of Study   Effectiveness of combined sensory integration and behavioral intervention on insistence of sameness in daily routine among children with Autism Spectrum disorder Disorder (ASD) 
Trial Acronym  SENSE B 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kishor Muthukumar 
Designation  PG student  
Affiliation  Chettinad Academy of Research and Education 
Address  OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam. Rajiv Gandhi Salai Kelambakkam TN 603103
OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam. Rajiv Gandhi Salai Kelambakkam TN 603103
Chennai
TAMIL NADU
603103
India 
Phone  8072285303  
Fax    
Email  kishormot7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrBhuvaneshwari S 
Designation  Assisstant Professor 
Affiliation  Chettinad Academy of Research and Education 
Address  OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam.
OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam.
Chennai
TAMIL NADU
603103
India 
Phone  9840016032  
Fax    
Email  bhuvaneshwaris@care.edu.in  
 
Details of Contact Person
Public Query
 
Name  DrBhuvaneshwari S 
Designation  Assisstant Professor 
Affiliation  Chettinad Academy of Research and Education 
Address  OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam.
OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam.
Chennai
TAMIL NADU
603103
India 
Phone  9840016032  
Fax    
Email  bhuvaneshwaris@care.edu.in  
 
Source of Monetary or Material Support  
OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam. 
 
Primary Sponsor  
Name  Kishor Muthukumar 
Address  OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam. Rajiv Gandhi Salai Kelambakkam TN 603103 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kishor Muthukumar  Chettnad school of Occupational Therapy   Chettinad Academy of Research and Education Chettinad Health City Rajiv Gandhi Salai Kelambakkam TN 603103
Chennai
TAMIL NADU 
8072285303

kishormot7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CARE IHEC-I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  sensory integration and behavioral intervention   Control group participant will receive common occupational intervention Experimental group receive both behavior and sensory intervention. sensory integration and behavioral intervention Duration: 45 minutes per session for 8weeks (3days/weeks).  
Comparator Agent  WeeFIM   Effect of intervention will be assessed by comparing the results of the pre test collected in the beginning and post test after completing the of 8 weeks intervention period  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  12.00 Year(s)
Gender  Male 
Details  Autism Spectrum Disorder children with both sensory and behavioral issues age group of 7-12 years of age. Diagnosed with Autism Spectrum Disorder (DSM-5 criteria) 
 
ExclusionCriteria 
Details  Children with other behavioural condition like ADHD ,ODD, Conduct disorder and below 7 years of age and teenagers

Significant physical disabilities preventing participation

Severe cognitive impairment IQ less than 50 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
WeeFIM
Repetitive Behavior Scale-Revised (RBS-R)  
2 months (8 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Autism Spectrum Disorder ASD is a complex neuro developmental condition characterized by deficits in social communication and the presence of restricted and repetitive behaviors RRBs including Insistence on Sameness IS a strong preference for routine and resistance to change IS behaviors often interfering with learning adaptability and daily functioning particularly in early childhood when developmental flexibility is crucial

While Behavioral Interventions like Functional Communication Training are effective in addressing maladaptive behaviors and Sensory Integration Therapy SIT is commonly used to manage sensory processing difficulties very few studies have evaluated the combined effectiveness of these approaches in reducing IS behaviors specifically related to daily routines

Children with ASD often exhibit IS as a coping mechanism for underlying sensory dysregulation Therefore a combined approach targeting both behavioral rigidity and sensory processing dysfunction may be more effective than isolated interventions This dual focus intervention could provide meaningful improvements in behavioral flexibility independence and overall quality of life

Given the limited empirical evidence from Indian contexts there is a pressing need for research to validate culturally and contextually relevant interventions that address IS in daily life among Indian children with ASD

Insistence on sameness IS is a core feature of autism spectrum disorder ASD characterized by a preference for routines resistance to change and repetitive behaviors These behaviors often manifest in daily routines leading to significant challenges in flexibility and adaptability The repetitive behavior scale revised RBS R is a commonly used tool to assess the severity of IS behaviors in individuals with ASD Kennedy krieger institute

Sensory processing dysfunction including hypersensitivity or hyposensitivity to sensory stimuli is prevalent among children with ASD This dysfunction can exacerbate IS behaviors as individuals may seek predictability to manage sensory overload Sensory integration therapy SIT aims to address these sensory processing issues by providing structured sensory experiences to help individuals modulate their sensory responses Behavioral interventions such focus on modifying maladaptive behaviors and promoting functional skills through reinforcement strategies

When combined sit and behavioral interventions offer a comprehensive approach to managing IS behaviors by addressing both sensory and behavioral components Previous studies have demonstrated the effectiveness of individual interventions in reducing IS behaviors However there is limited research exploring the combined impact of SIT and behavioral interventions on IS in daily routines among children with ASD This gap underscores the need for empirical studies to evaluate the synergistic effects of these interventions


 
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